Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of cyclosporine mucoadhesive gel at two different concentrations in the topical treatment of lichen planus in the oral mucosa.

    Summary
    EudraCT number
    		 2017-000791-29
    Trial protocol
    		 ES  
    Global end of trial date
    08 Oct 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Nov 2021
    First version publication date
    11 Nov 2021
    Other versions
    Summary report(s)
    		 Final report summary

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CICLO-LPO
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Clínica Universidad de Navarra
    Sponsor organisation address
    Avda. Pío XII, 36, Pamplona, Spain, 31008
    Public contact
    UCEC, Clínica Universidad de Navarra, 34 9482554002725, ucicec@unav.es
    Scientific contact
    UCEC, Clínica Universidad de Navarra, 34 9482554002725, ucicec@unav.es
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Aug 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Oct 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Oct 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of two different concentrations of cyclosporin A (0.5% and 2%) cyclosporin topical on a mucoadhesive gel in the topical treatment for 6 weeks of oral mucosa lichens.
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Jul 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 7
    Worldwide total number of subjects
    7
    EEA total number of subjects
    7
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    4
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 7 patients were included instead of the 28 evaluable patients indicated in the protocol, due to the shortage of study medication.

    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer
    Blinding implementation details
    The organoleptic characteristics of the preparations will be similar to avoid the blinding opening. A single specialist (blinded for treatment) will assess the extent of the mucosa. A different specialist, also blind, by analyzing the photographs and coded images.

    Arms
    Arm title
    		 Treatment
    Arm description
    		 Each patient's kit will contain 2 x 25g aluminum tubes of study drug or placebo. Thus, each patient will receive 2 kits with two tubes each: a tube that will contain the drug under study (cyclosporine 2% or 0.5%) and another tube that will contain a placebo of the drug. Each patient's kit will be labeled and each kit will be dispensed on visits 1 and 4
    Arm type
    		 Experimental

    Investigational medicinal product name
    cyclosporine 2% or 0.5%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    cyclosporine 2% or 0.5%

    Number of subjects in period 1
    		Treatment
    Started
    7
    Completed
    7

    Baseline characteristics

    		 Close Top of page

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 Each patient's kit will contain 2 x 25g aluminum tubes of study drug or placebo. Thus, each patient will receive 2 kits with two tubes each: a tube that will contain the drug under study (cyclosporine 2% or 0.5%) and another tube that will contain a placebo of the drug. Each patient's kit will be labeled and each kit will be dispensed on visits 1 and 4

    Primary: efficacy of two different concentrations of cyclosporin

    		 Close Top of page
    End point title
    		 efficacy of two different concentrations of cyclosporin [1]
    End point description
    A descriptive analysis will be carried out by calculating the frequencies and percentages for the qualitative variables, and the medians and ranges of the quantitative variables.
    End point type
    Primary
    End point timeframe
    Evaluations will be performed by a specialist without knowing the type of treatment received at baseline visits, at weeks 2, 4 and 6.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was added because the website does not allow to set the design of this study. Double blind Intraindividual randomized placebo controlled trial (each patient received both, placebo and treatment). Placebo and control areas was compared using the Wilcoxon test. Pre-specified P-value was 0.05 for statistical significance.
    End point values
    		 Treatment
    Number of subjects analysed
    7 [2]
    Units: Percentage and frecuency
    7
    Notes
    [2] - 7 patients were included instead of the 28 evaluable patients indicated in the protocol
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    1 year
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 -

    Serious adverse events
    		 Treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 7 (100.00%)
    Nervous system disorders
    Migraine headache
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    General disorders and administration site conditions
    Stinging
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Gastric reflux
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Gastrointestinal disorders
    inflammation of the gum
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Erosive lichen planus
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Knee pain
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Infections and infestations
    DENTAL INFLAMMATION
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    sinusitis
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Aug 2017
    Protocol amendment

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    08 Oct 2018
    Due to a shortage of medication, recruitment had to be stopped. Given the refusal of the manufacturer to provide more medication, we had to close the trial for this reason
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed Apr 24 20:50:11 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA